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The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and displav. an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text is related to a 510(k) premarket notification for a medical device called the "Profile 1320 Laser System." This document establishes the substantial equivalence of the device to existing predicate devices based on design, functional features, and intended use.

Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The document focuses on regulatory compliance through substantial equivalence to predicate devices, rather than detailed performance metrics or clinical study results as you would expect for AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the necessary information is not present in the provided 510(k) summary. This type of regulatory submission typically does not include the detailed performance study information you are asking for if the device is deemed substantially equivalent to a predicate device.

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The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision. ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided documents are a 510(k) summary and FDA clearance letter for the Sciton Profile 1320 Laser System. These documents primarily focus on regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted directly from these documents. These types of studies are typically found in more detailed technical reports or clinical trial summaries, which are not included here.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided documents, specific quantitative acceptance criteria or reported device performance metrics (e.g., precision, accuracy, sensitivity, specificity for a specific clinical task) are not available. The 510(k) summary focuses on the device's technical specifications and intended use.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not available in the provided documents. The clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical performance study detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not available in the provided documents.

4. Adjudication Method for the Test Set:

This information is not available in the provided documents.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/not available. The Sciton Profile 1320 Laser System is a medical laser for surgical and dermatological procedures, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable/not available. As noted above, this device is a laser system, not an algorithm.

7. The Type of Ground Truth Used:

This information is not available in the provided documents. When assessing laser systems, "ground truth" typically refers to the confirmed clinical outcome or tissue effect, which would be assessed in clinical trials. However, the details of such assessments are not present here.

8. The Sample Size for the Training Set:

This information is not applicable/not available. This device is a laser system, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable/not available. This device is a laser system, not a machine learning algorithm.

Summary of Device and Regulatory Context (from provided documents):

• Device Trade Name: Profile 1320 Laser System
• Common Name: Nd:YAG Laser System
• Intended Use: For use in general surgery and dermatology for incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.
• Predicate Device: CoolTouch Nd:YAG Laser System (K003715 and K014035)
• Regulatory Pathway: 510(k) clearance, based on substantial equivalence to the predicate device. This pathway does not typically require the detailed clinical performance studies that would include the specific acceptance criteria and study details requested, unless there are new technological characteristics or different intended uses that raise different safety and effectiveness questions.

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The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific acceptance criteria. This document is a 510(k) premarket notification summary for a laser system, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance study results against defined acceptance criteria.

The 510(k) summary provided describes:

• Device Trade Name: Profile 1320 Laser System
• Common Name: Nd:YAG Laser System
• Intended Use: "The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue."
• Predicate Device: CoolTouch Nd:YAG Laser System (K002347)
• Rationale for Substantial Equivalence: It states the device "shares the same indications for use, similar design features (including wavelength, laser medium, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate device."

This type of submission focuses on comparing the new device to an existing one to show it's "substantially equivalent," meaning it's as safe and effective as the predicate device, and doesn't typically include detailed clinical studies with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) or de novo submission might.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided 510(k) summary.

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